Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer

Sponsor

Second Hospital of Shanxi Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05160857

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a single arm, single center and exploratory clinical study, which aims to explore the efficacy and safety of hetropapa ethanolamine tablets in the treatment of thrombocytopenia caused by concurrent radiotherapy and chemotherapy of cervical cancer. The primary end point was the proportion of subjects who were effective after treatment with hetropapa in the first cycle after treatment, that is, the platelet value recovered to ≥ 100 x 109 / L after treatment. The main inclusion criteria were: voluntary participation in the trial and signing informed consent; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet < 75 × 109/L； At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle.

Condition or Disease	Intervention/Treatment	Phase
Tumor Chemotherapy-related Thrombocytopenia	Drug: Herombopag Olamine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer

Anticipated Study Start Date :

Dec 31, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: test group	Drug: Herombopag Olamine The initial dose of hetropapa is recommended to be 7.5mg, once a day, oral on an empty stomach, and can only be eaten after oral administration for 2 hours, so as to avoid taking it with meals.

Arm

Intervention/Treatment

Experimental: test group

Drug: Herombopag Olamine

The initial dose of hetropapa is recommended to be 7.5mg, once a day, oral on an empty stomach, and can only be eaten after oral administration for 2 hours, so as to avoid taking it with meals.

Outcome Measures

Primary Outcome Measures

Platelet index [Blood routine tests were conducted every three days within 14 days after taking the drug]
Destroy after use

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Voluntarily participate in the trial and sign the informed consent form; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet < 75 × 109/L At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle

Exclusion Criteria:

Screening or baseline platelet value < 30 × 109/L Suffering from the following hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, bone marrow proliferative diseases, multiple myeloma and myelodysplastic syndrome; Thrombocytopenia caused by causes other than CIT occurred within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infection and bleeding; Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal tract or central nervous system bleeding; Neutrophil absolute value < 1.0 × 109 / L, hemoglobin < 80g / L; It is allowed to use granulocyte colony stimulating factor, erythrocyte and EPO infusion in line with clinical routine; The researcher believes that participating in the trial has a great risk to the subject's health or safety, or other situations that may affect the efficacy evaluation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030000

Sponsors and Collaborators

Second Hospital of Shanxi Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wu jin rong, researcher, Second Hospital of Shanxi Medical University

ClinicalTrials.gov Identifier:

NCT05160857

Other Study ID Numbers:

SecondShanxiMU

First Posted:

Dec 16, 2021

Last Update Posted:

Dec 16, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Thrombocytopenia

Study Results

No Results Posted as of Dec 16, 2021